Tecartus (Brexucabtagene Autoleucel) First and Only CAR T in Europe to Receive Positive CHMP Opinion to Treat Adults 26+ with r/r ALL

If Approved, it will Address a Significant Unmet Need for a Patient Population with Limited Treatment Options

SANTA MONICA, Calif.--(BUSINESS WIRE)--Kite, a Gilead Company (Nasdaq: GILD), today announces that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Tecartus (brexucabtagene autoleucel) for the treatment of adult patients 26 years of age and above with relapsed or refractory (r/r) B-cell precursor acute lymphoblastic leukemia (ALL). If approved, Tecartus will be the first and only Chimeric Antigen Receptor (CAR) T-cell therapy for this population of patients who have limited treatment options. Half of adults with ALL will relapse, and median overall survival (OS) for this group is only approximately eight months with current standard-of-care treatments.

Kites goal is clear: to bring the hope of survival to more patients with cancer around the world through cell therapy, said Christi Shaw, CEO, Kite. Todays CHMP positive opinion in adult ALL brings us a step closer to delivering on the promise that cell therapies have to transform the way cancer is treated.

Following this positive opinion, the European Commission will now review the CHMP opinion; the final decision on the Marketing Authorization is expected in the coming months.

Adults with relapsed or refractory ALL often undergo multiple treatments including chemotherapy, targeted therapy and stem cell transplant, creating a significant burden on a patients quality of life, said Max S. Topp, MD, professor and head of Hematology, University Hospital of Wuerzburg, Germany. If approved, patients in Europe will have a meaningful advancement in treatment. Tecartus has demonstrated durable responses, suggesting the potential for long-term remission and a new approach to care.

Results from the ZUMA-3 international multicenter, single-arm, open-label, registrational Phase 1/2 study of adult patients (18 years old) with relapsed or refractory ALL, demonstrated that 71% of the evaluable patients (n=55) achieved complete remission (CR) or CR with incomplete hematological recovery (CRi) with a median follow-up of 26.8 months. In an extended data set of all patients dosed with the pivotal dose (n=78) the median overall survival for all patients was more than two years (25.4 months) and almost four years (47 months) for responders (patients who achieved CR or CRi). Among efficacy-evaluable patients, median duration of remission (DOR) was 18.6 months. Among the patients treated with Tecartus at the target dose (n=100), Grade 3 or higher cytokine release syndrome (CRS) and neurologic events occurred in 25% and 32% of patients, respectively, and were generally well-managed.

About ZUMA-3

ZUMA-3 is an ongoing international multicenter (US, Canada, EU), single arm, open label, registrational Phase 1/2 study of Tecartus in adult patients (18 years old) with ALL whose disease is refractory to or has relapsed following standard systemic therapy or hematopoietic stem cell transplantation. The primary endpoint is the rate of overall complete remission or complete remission with incomplete hematological recovery by central assessment. Duration of remission and relapse-free survival, overall survival, minimal residual disease (MRD) negativity rate, and allo-SCT rate were assessed as secondary endpoints.

About Acute Lymphoblastic Leukemia

ALL is an aggressive type of blood cancer that develops when abnormal white blood cells accumulate in the bone marrow until there isnt any room left for blood cells to form. In some cases, these abnormal cells invade healthy organs and can also involve the lymph nodes, spleen, liver, central nervous system and other organs. The most common form is B cell precursor ALL. Globally, approximately 64,000 people are diagnosed with ALL each year, including around 3,300 people in Europe.

About Tecartus

Please see full FDA Prescribing Information, including BOXED WARNING and Medication Guide.

Tecartus is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of:

This indication is approved under accelerated approval based on overall response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

U.S. IMPORTANT SAFETY INFORMATION

BOXED WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITIES

Cytokine Release Syndrome (CRS), including life-threatening reactions, occurred following treatment with Tecartus. In ZUMA-2, CRS occurred in 91% (75/82) of patients receiving Tecartus, including Grade 3 CRS in 18% of patients. Among the patients who died after receiving Tecartus, one had a fatal CRS event. The median time to onset of CRS was three days (range: 1 to 13 days) and the median duration of CRS was ten days (range: 1 to 50 days). Among patients with CRS, the key manifestations (>10%) were similar in MCL and ALL and included fever (93%), hypotension (62%), tachycardia (59%), chills (32%), hypoxia (31%), headache (21%), fatigue (20%), and nausea (13%). Serious events associated with CRS included hypotension, fever, hypoxia, tachycardia, and dyspnea.

Ensure that a minimum of two doses of tocilizumab are available for each patient prior to infusion of Tecartus. Following infusion, monitor patients for signs and symptoms of CRS daily for at least seven days for patients with MCL and at least 14 days for patients with ALL at the certified healthcare facility, and for four weeks thereafter. Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time. At the first sign of CRS, institute treatment with supportive care, tocilizumab, or tocilizumab and corticosteroids as indicated.

Neurologic Events, including those that were fatal or life-threatening, occurred following treatment with Tecartus. Neurologic events occurred in 81% (66/82) of patients with MCL, including Grade 3 in 37% of patients. The median time to onset for neurologic events was six days (range: 1 to 32 days) with a median duration of 21 days (range: 2 to 454 days) in patients with MCL. Neurologic events occurred in 87% (68/78) of patients with ALL, including Grade 3 in 35% of patients. The median time to onset for neurologic events was seven days (range: 1 to 51 days) with a median duration of 15 days (range: 1 to 397 days) in patients with ALL. For patients with MCL, 54 (66%) patients experienced CRS before the onset of neurological events. Five (6%) patients did not experience CRS with neurologic events and eight patients (10%) developed neurological events after the resolution of CRS. Neurologic events resolved for 119 out of 134 (89%) patients treated with Tecartus. Nine patients (three patients with MCL and six patients with ALL) had ongoing neurologic events at the time of death. For patients with ALL, neurologic events occurred before, during, and after CRS in 4 (5%), 57 (73%), and 8 (10%) of patients; respectively. Three patients (4%) had neurologic events without CRS. The onset of neurologic events can be concurrent with CRS, following resolution of CRS or in the absence of CRS.

The most common neurologic events (>10%) were similar in MCL and ALL and included encephalopathy (57%), headache (37%), tremor (34%), confusional state (26%), aphasia (23%), delirium (17%), dizziness (15%), anxiety (14%), and agitation (12%). Serious events including encephalopathy, aphasia, confusional state, and seizures occurred after treatment with Tecartus.

Monitor patients daily for at least seven days for patients with MCL and at least 14 days for patients with ALL at the certified healthcare facility and for four weeks following infusion for signs and symptoms of neurologic toxicities and treat promptly.

REMS Program: Because of the risk of CRS and neurologic toxicities, Tecartus is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Yescarta and Tecartus REMS Program which requires that:

Hypersensitivity Reactions: Serious hypersensitivity reactions, including anaphylaxis, may occur due to dimethyl sulfoxide (DMSO) or residual gentamicin in Tecartus.

Severe Infections: Severe or life-threatening infections occurred in patients after Tecartus infusion. Infections (all grades) occurred in 56% (46/82) of patients with MCL and 44% (34/78) of patients with ALL. Grade 3 or higher infections, including bacterial, viral, and fungal infections, occurred in 30% of patients with ALL and MCL. Tecartus should not be administered to patients with clinically significant active systemic infections. Monitor patients for signs and symptoms of infection before and after Tecartus infusion and treat appropriately. Administer prophylactic antimicrobials according to local guidelines.

Febrile neutropenia was observed in 6% of patients with MCL and 35% of patients with ALL after Tecartus infusion and may be concurrent with CRS. The febrile neutropenia in 27 (35%) of patients with ALL includes events of febrile neutropenia (11 (14%)) plus the concurrent events of fever and neutropenia (16 (21%)). In the event of febrile neutropenia, evaluate for infection and manage with broad spectrum antibiotics, fluids, and other supportive care as medically indicated.

In immunosuppressed patients, life-threatening and fatal opportunistic infections have been reported. The possibility of rare infectious etiologies (e.g., fungal and viral infections such as HHV-6 and progressive multifocal leukoencephalopathy) should be considered in patients with neurologic events and appropriate diagnostic evaluations should be performed.

Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with drugs directed against B cells. Perform screening for HBV, HCV, and HIV in accordance with clinical guidelines before collection of cells for manufacturing.

Prolonged Cytopenias: Patients may exhibit cytopenias for several weeks following lymphodepleting chemotherapy and Tecartus infusion. In patients with MCL, Grade 3 or higher cytopenias not resolved by Day 30 following Tecartus infusion occurred in 55% (45/82) of patients and included thrombocytopenia (38%), neutropenia (37%), and anemia (17%). In patients with ALL who were responders to Tecartus treatment, Grade 3 or higher cytopenias not resolved by Day 30 following Tecartus infusion occurred in 20% (7/35) of the patients and included neutropenia (12%) and thrombocytopenia (12%); Grade 3 or higher cytopenias not resolved by Day 60 following Tecartus infusion occurred in 11% (4/35) of the patients and included neutropenia (9%) and thrombocytopenia (6%). Monitor blood counts after Tecartus infusion.

Hypogammaglobulinemia: B cell aplasia and hypogammaglobulinemia can occur in patients receiving treatment with Tecartus. Hypogammaglobulinemia was reported in 16% (13/82) of patients with MCL and 9% (7/78) of patients with ALL. Monitor immunoglobulin levels after treatment with Tecartus and manage using infection precautions, antibiotic prophylaxis, and immunoglobulin replacement.

The safety of immunization with live viral vaccines during or following Tecartus treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least six weeks prior to the start of lymphodepleting chemotherapy, during Tecartus treatment, and until immune recovery following treatment with Tecartus.

Secondary Malignancies may develop. Monitor life-long for secondary malignancies. In the event that one occurs, contact Kite at 1-844-454-KITE (5483) to obtain instructions on patient samples to collect for testing.

Effects on Ability to Drive and Use Machines: Due to the potential for neurologic events, including altered mental status or seizures, patients are at risk for altered or decreased consciousness or coordination in the 8 weeks following Tecartus infusion. Advise patients to refrain from driving and engaging in hazardous activities, such as operating heavy or potentially dangerous machinery, during this period.

Adverse Reactions: The most common non-laboratory adverse reactions ( 20%) were fever, cytokine release syndrome, hypotension, encephalopathy, tachycardia, nausea, chills, headache, fatigue, febrile neutropenia, diarrhea, musculoskeletal pain, hypoxia, rash, edema, tremor, infection with pathogen unspecified, constipation, decreased appetite, and vomiting. The most common serious adverse reactions ( 2%) were cytokine release syndrome, febrile neutropenia, hypotension, encephalopathy, fever, infection with pathogen unspecified, hypoxia, tachycardia, bacterial infections, respiratory failure, seizure, diarrhea, dyspnea, fungal infections, viral infections, coagulopathy, delirium, fatigue, hemophagocytic lymphohistiocytosis, musculoskeletal pain, edema, and paraparesis.

About Kite

Kite, a Gilead Company, is a global biopharmaceutical company based in Santa Monica, California, with manufacturing operations in North America and Europe. Kites singular focus is cell therapy to treat and potentially cure cancer. As the cell therapy leader, Kite has more approved CAR T indications to help more patients than any other company. For more information on Kite, please visit http://www.kitepharma.com. Follow Kite on social media on Twitter (@KitePharma) and LinkedIn.

About Gilead Sciences

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the ability of Gilead and Kite to initiate, progress or complete clinical trials within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing and additional clinical trials, including those involving Tecartus; the risk that physicians may not see the benefits of prescribing Tecartus for the treatment of blood cancers; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and other factors are described in detail in Gileads Quarterly Report on Form 10-Q for the quarter ended March 31, 2022 as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead and Kite, and Gilead and Kite assume no obligation and disclaim any intent to update any such forward-looking statements.

U.S. Prescribing Information for Tecartus including BOXED WARNING, is available at http://www.kitepharma.com and http://www.gilead.com .

Kite, the Kite logo, Tecartus and GILEAD are trademarks of Gilead Sciences, Inc. or its related companies .

View source version on businesswire.com: https://www.businesswire.com/news/home/20220722005258/en/

Jacquie Ross, Investorsinvestor_relations@gilead.com

Anna Padula, Mediaapadula@kitepharma.com

Source: Gilead Sciences, Inc.

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Josh, Harper and Meagan in June 2022

Two years ago, Meagan stood in a hospital room at Seattle Childrens cradling her 1-year-old daughter, Harper, against her chest. Her fianc, Josh, huddled close to them and kissed the thinning hair on top of their babys head.

A feeding tube was routed through Harpers nose and her eyes were brimming with tears. Exhausted, she snuggled into her moms arms as a photographer took their picture.

Meagan and Josh feared those would be the last photos taken of their baby girl.

Six months before, Harper became seriously ill. After multiple visits to their pediatrician in Yakima, Meagan took her to an emergency room where blood tests revealed Harper had leukemia.

It was shocking, Meagan says. Thirty minutes later we were on an emergency flight to Seattle Childrens.

The family didnt return home for nearly two years.

The type of leukemia Harper had acute lymphoblastic leukemia (ALL) is typically harder to treat and has lower survival rates when it occurs in infants who are less than a year old.

Harpers case was exceptionally challenging. She didnt respond to standard chemotherapy, even after providers added a medication designed to sensitize her leukemia to the treatment.

Her care team, which included Seattle Childrens High-Risk Leukemia Program, believed a stem cell transplant would give Harper the best chance of surviving, but they had to eliminate the majority of her leukemia cells first.

Drs. Kasey Leger and Brittany Lee, Harpers primary oncologists, started her on a novel immunotherapy medication, called blinatumomab, which effectively destroyed many of her ALL cells.

Unfortunately, two weeks later, the team discovered some of Harpers ALL cells had morphed into a different blood cancer acute myeloid leukemia (AML). This rare occurrence, called lineage switch, occurs in less than 5% of infant ALL cases.

It was a roller coaster, Josh says. She didnt do anything they expected her to do. It felt like every day we had to come up with a new plan.

Drs. Leger and Lee gave Harper a different kind of chemotherapy that destroyed the new AML cells. Still, some of her ALL cells remained, so the team gave Harper blinatumomab again which finally suppressed her cancer enough for her to have a stem cell transplant just before her first birthday.

Harper and her mom, Meagan, celebrating Harpers first birthday shortly after her stem cell transplant

The team had done everything they could to get Harper healthy enough for a stem cell transplant, hopeful it would be the treatment that finally cured her. Tragically, Harpers leukemia was back less than a month later.

When leukemia comes back so soon after transplant, patients have very few treatment options, if any, says Dr. Corinne Summers, Harpers stem cell transplant specialist. Many patients will not survive long term.

Harpers parents were terrified they were going to lose her.

Her bone marrow was packed with leukemia, Josh remembers. You could tell the life was slipping out of her and she just looked like it was going to be the end.

After Harpers stem cell transplant failed, the family met with end-of-life specialists and scheduled a special photo session to create memories that they would carry forward

They struggled to decide if they should continue treatment.

How do you know when enough is enough? Meagan says. When do you say, We cant do this to her anymore? Harper couldnt tell us how she was feeling, so it was all our decision.

Meagan and Josh worked closely with the care team to decide what to do next.

Those conversations were emotional for all of us, says Dr. Lee. Thankfully, we had a close, trusting relationship with their family and were able to give recommendations that reflected what they wanted for their daughter and what they felt was most important.

After much consideration, Meagan and Josh decided Harper was strong enough to continue treatment.

Drs. Leger and Lee filed a compassionate use request with the Food and Drug Administration to give Harper an investigational chemotherapy drug called venetoclax. Unfortunately, the treatment didnt work.

Collaborating with the family, the team decided to try giving Harper blinatumomab one more time. There was no evidence suggesting the medication would work so soon after a bone marrow transplant and with such a high burden of leukemia, but within a week it eliminated 98% of Harpers cancer cells.

Family is a critical piece of the team, Dr. Leger says. And Harper is fortunate to have amazing parents who were at her bedside 24/7 and had a beautiful way of advocating for her. They challenged us to leave no stone unturned and partnered with us throughout her treatment to keep figuring out a way forward.

With Harpers leukemia under control, the team searched for a way to wipe out any remaining cancer cells and keep her disease from coming back. Doctors in Childrens Cancer and Blood Disorders Center lead national research groups such as the Childrens Oncology Group, so they have access to trials around the world. However, Harpers care team found the best treatment for her was at Seattle Childrens Hospital, in partnership with Seattle Childrens Therapeutics.

Harpers T-cells were removed through a process called apheresis before they were reprogrammed to target her cancer cells and infused back into her blood

Harper was enrolled in one of Childrens T-cell immunotherapy clinical trials. The treatment involves re-programming a patients T cells (a type of white blood cell) to target and destroy their cancer cells.

After her T-cell therapy, Harper was finally in remission.

Meagan cried with relief when she found out. Harper would not be here right now if it wasnt for everybody at Seattle Childrens, she says. From day one, theyve been comforting and compassionate. They bend over backwards to keep families involved and helped us fight for our child.

To keep her in remission, Harper was given six antigen-presenting cell boosters, which kept her reprogrammed T cells circulating through her blood longer. She received the last booster earlier this year and is still in remission today.

Harper had a very unique disease in that her leukemia manifested as both ALL and AML, says Dr. Leger. Thankfully, we have team members with deep expertise in each of those diseases. Having internationally recognized chemotherapy, transplant and immunotherapy specialists on our team allowed us to be creative with her care when she needed to go beyond the standard pathways.

Today, Harper is a joyful, boisterous 3-year-old who loves experimenting with musical toys and splashing around in her bath or kiddie pool. One of her favorite things to do is grab Meagan by the hair and squish their faces together.

Because of the treatments Harper received at such a young age and the extended time she spent in the hospital, Harper is behind on some developmental milestones like speaking and walking. Still, Meagan and Josh say shes catching up.

Shes starting to bloom and take off and its so nice to see, Meagan says. At the same time, we cant get too comfortable. We know how relentless her disease is and that it could come back one day.

Harper plays in a pool, one of her favorite activities, in June 2022

Harpers family encourages community members to support cancer research at Childrens so that new treatments can be developed for Harper and other kids like her.

Without donors, Harper probably wouldnt be alive right now, Josh says. The treatments she had were developed in just the last few years. If people dont step up and donate, those programs arent there. Those drugs arent invented. Cancer treatment has come a really long way and thats because of donors stepping up to make that happen.

Learn more about Seattle Childrens High-Risk Leukemia Program and Cancer and Blood Disorders Center.

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New Jersey, United States TheStem Cell TherapyMarket research guides new entrants to obtain precise market data and communicates with customers to know their requirements and preferences. It spots outright business opportunities and helps to bring new products into the market. It identifies opportunities in the marketplace. It aims at doing modifications in the business to make business procedures smooth and make business forward. It helps business players to make sound decision making. Stem Cell Therapy market report helps to reduce business risks and provides ways to deal with upcoming challenges. Market information provided here helps new entrants to take informed decisions making. It emphasizes on major regions of the globe such as Europe, North America, Asia Pacific, Middle East, Africa, and Latin America along with their market size.

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Key Players Mentioned in the Stem Cell Therapy Market Research Report:

Osiris Therapeutics Medipost Co. Ltd., Anterogen Co. Ltd., Pharmicell Co. Ltd., HolostemTerapieAvanzateSrl, JCR Pharmaceuticals Co. Ltd., Nuvasive RTI Surgical Allosource

Stem Cell TherapyMarket report consists of important data about the entire market environment of products or services offered by different industry players. It enables industries to know the market scenario of a particular product or service including demand, supply, market structure, pricing structure, and trend analysis. It is of great assistance in the product market development. It further depicts essential data regarding customers, products, competition, and market growth factors. Stem Cell Therapy market research benefits greatly to make the proper decision. Future trends are also revealed for particular products or services to help business players in making the right investment and launching products into the market.

Stem Cell TherapyMarket Segmentation:

Stem Cell Therapy Market, By Cell Source

Adipose Tissue-Derived Mesenchymal Stem Cells Bone Marrow-Derived Mesenchymal Stem Cells Cord Blood/Embryonic Stem Cells Other Cell Sources

Stem Cell Therapy Market, By Therapeutic Application

Musculoskeletal Disorders Wounds and Injuries Cardiovascular Diseases Surgeries Gastrointestinal Diseases Other Applications

Stem Cell Therapy Market, By Type

Allogeneic Stem Cell Therapy Autologous Stem Cell Therapy

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For Prepare TOC Our Analyst deep Researched the Following Things:

Report Overview:It includes major players of the Stem Cell Therapy market covered in the research study, research scope, market segments by type, market segments by application, years considered for the research study, and objectives of the report.

Global Growth Trends:This section focuses on industry trends where market drivers and top market trends are shed light upon. It also provides growth rates of key producers operating in the Stem Cell Therapy market. Furthermore, it offers production and capacity analysis where marketing pricing trends, capacity, production, and production value of the Stem Cell Therapy market are discussed.

Market Share by Manufacturers:Here, the report provides details about revenue by manufacturers, production and capacity by manufacturers, price by manufacturers, expansion plans, mergers and acquisitions, and products, market entry dates, distribution, and market areas of key manufacturers.

Market Size by Type:This section concentrates on product type segments where production value market share, price, and production market share by product type are discussed.

Market Size by Application:Besides an overview of the Stem Cell Therapy market by application, it gives a study on the consumption in the Stem Cell Therapy market by application.

Production by Region:Here, the production value growth rate, production growth rate, import and export, and key players of each regional market are provided.

Consumption by Region:This section provides information on the consumption in each regional market studied in the report. The consumption is discussed on the basis of country, application, and product type.

Company Profiles:Almost all leading players of the Stem Cell Therapy market are profiled in this section. The analysts have provided information about their recent developments in the Stem Cell Therapy market, products, revenue, production, business, and company.

Market Forecast by Production:The production and production value forecasts included in this section are for the Stem Cell Therapy market as well as for key regional markets.

Market Forecast by Consumption:The consumption and consumption value forecasts included in this section are for the Stem Cell Therapy market as well as for key regional markets.

Value Chain and Sales Analysis:It deeply analyzes customers, distributors, sales channels, and value chain of the Stem Cell Therapy market.

Key Findings:This section gives a quick look at the important findings of the research study.

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Abstract: Diabetes mellitus with hyperglycaemia is a major risk factor for malignant cardiac dysrhythmias. However, the underlying mechanisms remain unclear, especially during the embryonic developmental phase of the heart. This study investigated the effect of hyperglycaemia on the pulsatile activity of stem cell-derived cardiomyocytes. Mouse embryonic stem cells (mESCs) were differentiated into cardiac-like cells through embryoid body (EB) formation, in either baseline glucose or high glucose conditions. Action potentials (APs) were recorded using a voltage-sensitive fluorescent dye and gap junction activity was evaluated using scrape-loading lucifer yellow dye transfer assay. Molecular components were detected using immunocytochemistry and immunoblot analyses. High glucose decreased the spontaneous beating rate of EBs and shortened the duration of onset of quinidine-induced asystole. Furthermore, it altered AP amplitude, but not AP duration, and had no impact on the expression of the hyperpolarisation-activated cyclic nucleotide-gated isoform 4 (HCN4) channel nor on the EB beating rate response to ivabradine nor isoprenaline. High glucose also decreased both the intercellular spread of lucifer yellow within an EB and the expression of the cardiac gap junction protein connexin 43 as well as upregulated the expression of transforming growth factor beta 1 (TGF1) and phosphorylated Smad3. High glucose suppressed the autorhythmicity and gap junction conduction of mESC-derived cardiomyocytes, via mechanisms probably involving TGF1/Smad3 signalling. The results allude to glucotoxicity related proarrhythmic effects, with potential clinical implications in foetal diabetic cardiac disease.

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NASA and Cedars-Sinai Medical Center are launching stem cells into space. In the study, funded by NASA and being conducted by scientists at Cedars-Sinai Medical Center in Los Angeles, the stem cells have been sent into space and will orbit for just over a months time to determine whether they grow differently without G-force.

A remotely controlled container of cells, with reagents and equipment needed to remotely sustain the cells, arrived at the International Space Station over the weekend. Two queries are presented alongside the launch details: do cells age differently in low orbit and can the Earthly challenges of stem cell growth amplification be overcome in space?

The human body is comprised of a full library of cell types, cataloged by specialty and location such as the striated cardiac muscles or the branching neurons in the brain. Each of these cells began as a raw stem cell and has developed in a particular manner. The cells can multiply to become a plentiful stem cell line under the correct conditions, but laboratory settings that would generate the quantity needed for medicinal purposes pose challenges that require innovative thinking.

Despite being featured in many biologic candidates currently under research and development and in clinical trials, mass-producing stem cells for use in these therapeutics isnt feasible. To prevent conglomeration or losing the stem cells at the bottom of a reactor tank, the bioreactor must be stirred at a rate that causes probable cell death. The end result is very few stem cells suitable for therapeutic and research use. By launching stem cells into space, the Cedars-Sinai research team is hoping to overcome these production limitations.

With stem cells, the possibilities and applications are increasing each day. They can work as models for testing drug safety and efficacy, thus reducing the burden placed on animal model research, be used as regenerative cells for those that have suffered damage as a result of injury or disease and even as a basic tool to help researchers further understand the human body.

By pushing the boundaries like this, its knowledge and its science and its learning, Clive Svendsen, executive director at the Cedars-Sinai Regenerative Medicine Institute, commented. Svendsen has sent a part of himself along with the project, as the donor of the stem cells.

Various other studies are being conducted by research teams around the globe in an effort to better understand the potential of stem cells.

Just last week, researchers from the University of Malta announced the launch of a similar mission that will be conducted aboard a SpaceX craft. The Maleth II project is the second installment of the Maleth Program that is designed to evaluate how human skin tissue cell genetics react to low earth orbit. A remotely controlled biocube will orbit the Earth for 60 days while the single cells are analyzed for changes.

The student researchers at the university are being directly supported by Maltas national Research, Innovation, Development Trust and the study itself is in collaboration with the Ministry of Foreign and European Affairs, Singleron Biotechnologies

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NASA's Solution to Stem Cell Production is Out of this World - BioSpace

Cardiac Stem Cells Comments Off on NASA’s Solution to Stem Cell Production is Out of this World – BioSpace | July 25th, 2022

Human samples

Rapid harvesting of cadaveric pancreatic tissues was obtained with informed consent from next of kin, from heart-beating, brain-dead donors, with research approval from the Human Research Ethics Committee at St Vincents Hospital, Melbourne. Pancreas from individuals without and with diabetes, islet, acinar and ductal samples were obtained as part of the research consented tissues through the National Islet Transplantation Programme (at Westmead Hospital, Sydney and the St Vincents Institute, Melbourne, Australia), HREC Protocol number: 011/04. The donor characteristics of islet cell donor isolations are presented in Table 1.

Islets were purified by intraductal perfusion and digestion of the pancreases with collagenase AF-1.24 (SERVA/Nordmark, Germany) followed by purification using Ficoll density gradients.25 Purified islets, from low-density gradient fractions and acinar/ductal tissue, from high-density fractions, were cultured in Miami Media 1A (Mediatech/Corning 98021, USA) supplemented with 2.5% human serum albumin (Australian Red Cross, Melbourne, VIC, Australia), in a 37C, 5% CO2 incubator.

Total RNA from human ex vivo pancreatic cells was isolated using TRIzol (Invitrogen) and RNeasy Kit (QIAGEN) including a DNase treatment. First-strand cDNA synthesis was performed using a high-capacity cDNA Reverse Transcription Kit (Applied Biosystems) according to the manufacturers instructions. cDNA primers were designed using oligoperfect designer (Thermo Fisher Scientific), as shown in Table 2. Briefly, quantitative RT-PCR analyses were undertaken using the PrecisionFast 2 qPCR Master Mix (Primerdesign) and primers using Applied Biosystems 7500 Fast Real-Time PCR System. Each qPCR reaction contained: 6.5l qPCR Master Mix, 0.5l of forward and reverse primers, 3.5l H2O and 2l of previously synthesised cDNA, diluted 1/20. Expression levels of specific genes were tested and normalised to 18s ribosomal RNA housekeeping gene.

Modification of Histone H3 and histone-associated Ezh2 protein signals were quantified in human pancreatic ductal epithelial cells (AddexBio) by the LI-COR Odyssey assay. The cells were treated with 5 or 10M of GSK 126 (S7061, Selleckchem) for 48h. Histones and their associated proteins were examined using an acid extraction and immunoblotting as described previously.18 Protein concentrations were determined using Coomassie Reagent (Sigma) with BSA as a standard. Equal amounts (3g) of acid extract were separated by Nu-PAGE (Invitrogen), transferred to a PVDF membrane (Immobilon-FL; Millipore) and then probed with antibodies against H3K27me3 (07449, Millipore), H3K27ac (ab4729, Abcam), H3K9me3 (ab8898, Abcam), H3K9me2 (ab1220, Abcam), H3K4me3 (39159, Active Motif), Ezh2 (#4905, Cell Signaling Technology), and total histone H3 (#14269, Cell Signaling Technology). Protein blotting signals were quantified by an infra-red imaging system (Odyssey; LI-COR). Modification of Histone H3 and histone-associated Ezh2 signals were quantified using total histone H3 signal as a loading control.

Chromatin immunoprecipitation assays in human exocrine cells were performed previously described.26,27 Cells were fixed for 10min with 1% formaldehyde and quenched for 10min with glycine (0.125M) solution. Fixed cells were resuspended in sodium dodecyl (lauryl) sulfate (SDS) lysis buffer (1% SDS, 10mM EDTA, 50mM Tris-HCl pH 8.1) including a protease inhibitor cocktail (Roche Diagnostics GmBH, Mannheim, Germany) and homogenised followed by incubation on ice for 5min. Soluble samples were sonicated to 200600bp and chromatin was resuspended in ChIP Dilution Buffer (0.01% SDS, 1.1% Triton X-100, 1.2mM EDTA, 16.7mM Tris-HCl pH 8.0, and 167mM NaCl) and 20l of Dynabeads Protein A (Invitrogen, Carlsbad, CA, USA) was added and pre-cleared. H3K27me3 antibody was used for immunoprecipitation of chromatin and incubated overnight at 4C as previously described.28 Immunoprecipitated DNA were collected by magnetic isolation, washed low salt followed by high salt buffers and eluted with 0.1M NaHCO3 with 1% SDS. Protein-DNA cross-links were reversed by adding Proteinase K (Sigma, St. Louis, MO, USA) and incubation at 62C for 2h. DNA was recovered using a Qiagen MinElute column (Qiagen Inc., Valencia, CA, USA). H3K27me3 content at the promoters of the INS, INS-IGF2, NGN3 and PDX1 genes were assessed by qPCR using primers designed from the integrative ENCODE resource.29 ChIP primers are shown in Table 3.

Insulin and glucagon localisation in human islets were assessed using paraffin sections (5m thickness) of human pancreas tissue fixed in 10% neutral-buffered formalin and stained with hematoxylin and eosin (H&E) or prepared for immunohistochemistry. Insulin and glucagon were detected using Guinea Pig anti-insulin (1/100, DAKO) or mouse anti-glucagon (1/50) mAbs (polyclonal Abs, Sigma-Aldrich).

Pharmacological inhibition of EZH2, human pancreatic exocrine cells were kept untreated or stimulated with 10M GSK-126 (S7061, Selleckchem) at a cell density of 1105 per well for 24h. After 24h of treatment, fresh Miami Media was added to the cells, which were treated again with 10 GSK-126 and cultured for a further 24h. All cell incubations were performed in Miami Media 1A (Mediatech/Corning 98-021, USA) supplemented with 2.5% human serum albumin (Australian Red Cross, Melbourne, VIC, Australia), in a cell culture incubator at 37C in an atmosphere of 5% CO2 for 48h using non-treated six-well culture plates (Corning).

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Inhibition of pancreatic EZH2 restores progenitor insulin in T1D donor | Signal Transduction and Targeted Therapy - Nature.com

Cardiac Stem Cells Comments Off on Inhibition of pancreatic EZH2 restores progenitor insulin in T1D donor | Signal Transduction and Targeted Therapy – Nature.com | July 25th, 2022

Shortly after I was told I would need a heart transplant, in August 2014, a cardiac nurse visited my house. She scanned the room and noticed my exercise equipment. "You're not going to use that are you?", she asked me. "Yes", I replied, "why?"

My heart was operating at 13 percent and I was firmly told I couldn't be doing that sort of thing in my condition. The nurse said she would send round a physiotherapist called Nikki Simpson to tell me what I could and couldn't do while doctors tried to figure out what was going on with my heart.

"Nikki Simpson?" I asked. It couldn't be. The woman I had once known with the same name was training to be a hairdresser, plus she'd married and moved away.

We had first met as teenagers at a club in the north of England in 1984. I had wavy shoulder length hair and she always had some sort of red leather gear on. Usually, I'm not the sharpest knife in the drawer when it comes to flirting, but I could tell she liked me straight away.

We dated for about six months. I didn't drink much so we would go on long drives and spend time with mutual friends, but for some reason the relationship just fizzled out. Nothing bad happened, we just drifted apart.

I lived a bachelor life for a while. Eventually I got married and had my son, Robert. Nikki got married and had a baby girl. We only lived a village away from each other but I never saw her once.

When my son was eight my first marriage broke down and I cared for Robert. It was the hardest thing to do, but we had the best time of our lives. I did date when my son was younger, but nobody seemed to understand that Robert came first.

For years I'd been extremely fit, I was a plasterer by trade and had always had physical jobs. But in February, 2014, when I was doing some work putting up billboards in Leeds, I couldn't breathe and kept falling to my knees.

I visited the emergency room with my sister. I was told I had pneumonia and given a course of antibiotics. I took them for two weeks but still couldn't breathe properly, so I was told it was likely I had a respiratory condition and to visit my doctor.

After months of being referred to and from the hospital, my doctor told me he thought I had heart failure. He organized an MRI scan which showed my heart was globally dilated and operating at a fraction of its normal function. They said it was likely down to a virus, but had no idea which one.

I went back the next week and the doctor sat there, clicking away on his keyboard. He glanced across at me and said: "We need to discuss a heart transplant." There I was, this strapping Yorkshireman who doesn't drink, doesn't smoke, doesn't do anything untoward, who has a dodgy heart. I stopped listening to anything he said. I went back to my doctor who told me to stop whatever I was doing, go home and watch TV on the sofa.

I started going for various scans and a cardiac nurse began to visit me and curate my drugs, which is when she mentioned about a physio helping me.

One day in August 2014, this nurse she knocked on the door and said "The physio is on her way, but I need to ask your permission for her to treat you because you have a history." I said it was fine.

When Nikki knocked on my door, I swung it open and shouted "f*** off!" I grabbed her, sat her on the kitchen table and gave her a big kiss on the cheek.

It just sort of took off from there. We started seeing each other when she came round to treat me. I would go to the gym with her to do exercises and she would call round for a cup of tea in the evenings.

Robert was doing his first year at university studying aeronautical engineering and I was concerned because he was driving a fair distance home every day just so I wasn't at home by myself. Eventually, Nikki said she'd move in with me so Robert could go and live the dream.

It was ace having her around. Even at this point, when I thought I was dying and there was no cure for me, it was like this angel had walked through the door and made my life better.

The relationship with Nikki was great, but I was going to the hospital a lot. The tablets used to steady you and make you comfortable I just couldn't tolerate. I got to the stage where I spent so much time in the hospital the porters recognised me.

It looked like I was going to die. I had a mate who had his suit washed three times for my funeral. Whenever I saw him he would say: "Are you still here?"

In October 2017, we were watching TV when an interview with the Heart Cells Foundation came on. They'd created a stem-cell procedure which took bone marrow from a patient's pelvis then injected it straight into the heart. I wanted it.

The next day I phoned them and they said to come down for some tests. I qualified for the procedure and in November 2018 went down to St Bartholomew's Hospital in London and had the treatment. It changed my life overnight.

This horrific thing I was thinking about; someone dying and me taking their heart, wasn't going to happen anymore. That was three and a half years ago. I had thought I was going to be dead in months without a transplant.

From day one of leaving the hospital, I haven't had any problems at all. I go down for a yearly check up and the consultant wants me to have the treatment again. They've never done it twice but think they might get some good results.

Nikki has been ace throughout all of this. We're looking to get married next year. I didn't want to get married before the treatment. I didn't want to be pushed down the aisle in a wheelchair or go for a meal after and end up in an ambulance. But, now, I'm getting fit, strong and strapping, so we want to go with it.

Looking back, it seems so strange that Nikki and I parted ways. I don't know if I believe in fate, but since I was first told I'd need a heart transplant we've lost my dad, my brother, two aunties and Nikki's dad. All these people who have gone, I was supposed to go before them. My perspective on life has always been to live it today, because you don't know what's going to come tomorrow.

Barry Newman, 55, from Wakefield, was a plasterer before undergoing pioneering treatment with the Heart Cells Foundation, an independent charity which has run a small unit at St Bartholomew's Hospital since 2016. Earlier this year he carried the baton at the Commonwealth Games relay.

All views expressed in this article are the author's own.

As told to Monica Greep

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'My Teen Sweetheart And I Drifted Apart. 30 Years Later I Made a Shocking Discovery' - Newsweek

Cardiac Stem Cells Comments Off on ‘My Teen Sweetheart And I Drifted Apart. 30 Years Later I Made a Shocking Discovery’ – Newsweek | July 25th, 2022

In brief

In 2020, the European Commission began a review of the EUs rules on blood, tissues and cells (BTC) used for medical treatments and therapies. Now the Commission haspublisheda draft legislative proposal to amend the rules.

The proposal does not recommend a complete overhaul: the EU will not change its definitions of blood, tissue and cell products. Yet it does promise a significant update to the two Directives published in the early 2000s that continue to govern the use of BTC components in the EU. Most importantly, the proposed legislation would be packaged as a Regulation rather than a Directive, meaning it would have a direct effect in the Member States.

The legislation sets out quality and safety requirements for allactivitiesfrom donation to human application (unless the donations are used to manufacture medicinal products or medical devices, in which case the legislation only applies to donation, collection and testing).

In its press release, the European Commission states that every year, EU patients are treated with 25 million blood transfusions (during surgery, emergency, cancer or other care), a million cycles of medically assisted reproduction, over 35,000 transplants of stem cells (mainly for blood cancers) and hundred thousands of replacement tissues (e.g., for orthopedic, skin, cardiac or eye problems). These therapies are only available thanks to the willingness of fellow citizens to make altruistic donations.

In the EU, the collection, processing and supply of each individual unit is typically organized on a local small-scale by public services, (academic) hospitals and non-profit actors.

Afteralmost 20years in place, the legislationno longer addressesthe scientific and technicalstate of the art and needs to be updated to take into account developments that have taken place in the sector.

How is the Commission planning to change BTC legislation in the EU? Here are three key takeaways from the draft proposal.

Compensating Doctors

The tissue and cell directive currently in force explicitly permits the Member States to compensate donors of tissue and cell products for their trouble. The corresponding blood Directive, however, contains no such provision: in its absence, different countries have developed their own guidelines on blood donor compensation.

That disparity is addressed in the draft Regulation, which would allow the Member States to reimburse donors of all human-derived products for losses related to their participation in adonation through fixed-rate allowances. Improving access to plasma donation, advocates of compensation schemes hope, could help the EU to bolster its patchy stockpiles of the essential fluid.

Emergency Planning

The Covid-19 pandemic demonstrated the fragility of healthcare networks that rely heavily on external sources for their products. Supply chain disruptions are a particular threat to the availability of plasma-derived medicines in the bloc since much of the EUs plasma is imported from the USA.

With this in mind, the Commission wants the Member States to develop emergency plans to cope with supply shocks. Countries would be required to maintain lines of communication that could be used in emergencies, establish authorities responsible for distribution in critical situations, and detect risks to their continued access to substances of human origin.

Detecting Risks

As might be expected, the draft Regulation introduces measures to protect the health and privacy of donors and donees. Screening is mandated to prevent patients from receiving diseased blood or cancerous cells. Technical systems should be in place to preserve the anonymity of all parties to a BTC transfer.

The burden of safeguarding is particularly heavy where assisted reproduction is concerned. It would be up to the Member States, under the draft legislation, to detect and mitigate genetic risks posed by donated reproductive cells.

If approved, it is thought that the revisions will be endorsed by 2023, with implementation beginning in 2024.

For further information, please contact Julia Gillert of our London office.

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EU: New Blood? Proposed Revisions to the EUs Blood, Tissues and Cells Rules - GlobalComplianceNews

Cardiac Stem Cells Comments Off on EU: New Blood? Proposed Revisions to the EUs Blood, Tissues and Cells Rules – GlobalComplianceNews | July 25th, 2022

Stem Cells Market: Introduction

According to the report, the globalstem cells marketwas valued at US$11.73Bn in 2020 and is projected to expand at a CAGR of10.4%from 2021 to 2028. Stem cells are defined as specialized cells of the human body that can develop into various different kinds of cells. Stem cells can form muscle cells, brain cells and all other cells in the body. Stem cells are used to treat various illnesses in the body.

North America was the largest market for stem cells in 2020. The region dominated the global market due to substantial investments in the field, impressive economic growth, increase in incidence of target chronic diseases, and technological progress. Moreover, technological advancements, increase in access to healthcare services, and entry of new manufacturers are the other factors likely to fuel the growth of the market in North America during the forecast period.

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Asia Pacific is projected to be a highly lucrative market for stem cells during the forecast period. The market in the region is anticipated to expand at a high CAGR during the forecast period. High per capita income has increased the consumption of diagnostic and therapy products in the region. Rapid expansion of the market in the region can be attributed to numerous government initiatives undertaken to improve the health care infrastructure. The market in Asia Pacific is estimated to expand rapidly compared to other regions due to shift in base of pharmaceutical companies and clinical research industries from developed to developing regions such as China and India. Moreover, changing lifestyles and increase in urbanization in these countries have led to a gradual escalation in the incidence of lifestyle-related diseases such as cancer, diabetes, and heart diseases.

Technological Advancements to Drive Market

Several companies are developing new approaches to culturing or utilizing stem cells for various applications. Stem cell technology is a rapidly developing field that combines the efforts of cell biologists, geneticists, and clinicians, and offers hope of effective treatment for various malignant and non-malignant diseases. The stem cell technology is progressing as a result of multidisciplinary effort, and advances in this technology have stimulated a rapid growth in the understanding of embryonic and postnatal neural development.

Adult Stem Cells Segment to Dominate Global Market

In terms of product type, the global stem cells market has been classified into adult stem cells, human embryonic stem cells, and induced pluripotent stem cells. The adult stem cells segment accounted for leading share of the global market in 2020. The capability of adult stem cells to generate a large number of specialized cells lowers the risk of rejection and enables repair of damaged tissues.

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Autologous Segment to Lead Market

Based on source, the global stem cells market has been bifurcated into autologous and allogenic. The autologous segment accounted for leading share of the global market in 2020. Autologous stem cells are used from ones own body to replace damaged bone marrow and hence it is safer and is commonly being practiced.

Regenerative Medicines to be Highly Lucrative

In terms of application, the global stem cells market has been categorized into regenerative medicines (neurology, oncology, cardiology, and others) and drug discovery & development. The regenerative medicines segment accounted for major share of the global market in 2020, as regenerative medicine is a stem cell therapy and the medicines are made using stem cells in order to repair an injured tissue. Increase in the number of cardiac diseases and other health conditions drive the segment.

Therapeutics Companies Emerge as Major End-users

Based on end-user, the global stem cells market has been divided into therapeutics companies, cell & tissue banks, tools & reagents companies, and service companies. The therapeutics companies segment dominated the global stem cells market in 2020. The segment is driven by increase in usage of stem cells to treat various illnesses in the body. Therapeutic companies are increasing the utilization of stem cells for providing various therapies. However, the cell & tissue banks segment is projected to expand at a high CAGR during the forecast period. Increase in number of banks that carry out research on stem cells required for tissue & cell growth and elaborative use of stem cells to grow various cells & tissues can be attributed to the growth of the segment.

Regional Analysis

In terms of region, the global stem cells market has been segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. North America dominated the global stem cells market in 2020, followed by Europe. Emerging markets in Asia Pacific hold immense growth potential due to increase in income levels in emerging markets such as India and China leading to a rise in healthcare spending.

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Competition Landscape

The global stem cells market is fragmented in terms of number of players. Key players in the global market include STEMCELL Technologies, Inc., Astellas Pharma, Inc., Cellular Engineering Technologies, Inc., BioTime, Inc., Takara Bio, Inc., U.S. Stem Cell, Inc., BrainStorm Cell Therapeutics, Inc., Cytori Therapeutics, Inc., Osiris Therapeutics, Inc., and Caladrius Biosciences, Inc.

Stem Cells Market, by Application

Stem Cells Market, by End-user

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Transparency Market Research, a global market research company registered at Wilmington, Delaware, United States, provides custom research and consulting services. The firm scrutinizes factors shaping the dynamics of demand in various markets.The insights and perspectives on the markets evaluate opportunities in various segments. The opportunities in the segments based on source, application, demographics, sales channel, and end-use are analysed, which will determine growth in the markets over the next decade.

Our exclusive blend of quantitative forecasting and trends analysis provides forward-looking insights for thousands of decision-makers, made possible by experienced teams of Analysts, Researchers, and Consultants. The proprietary data sources and various tools & techniques we use always reflect the latest trends and information. With a broad research and analysis capability, Transparency Market Research employs rigorous primary and secondary research techniques in all of its business reports.

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Stem Cells Market to Expand at a CAGR of 10.4% from 2021 to 2028 Travel Adventure Cinema - Travel Adventure Cinema

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Wilmington, Delaware, United States, July 18, 2022 (GLOBE NEWSWIRE) -- Transparency Market Research Inc.: The market value of the global cell separation technologies market is estimated to be over US$ 20.3 Bn by 2031, according to a research report by Transparency Market Research (TMR). Hence, the market is expected expand at a CAGR of 11.9% during the forecast period, from 2022 to 2031.

According to the TMR insights on the cell separation technologies market, the prevalence of chronic disorders including obesity, diabetes, cardiac diseases, cancer, and arthritis is being increasing around the world. Some of the key reasons for this situation include the sedentary lifestyle of people, increase in the older population, and rise in cigarette smoking and alcohol consumption across many developed and developing nations. These factors are expected to help in the expansion of the cell separation technologies market during the forecast period.

Players in the global cell separation technologies market are increasing focus on the launch of next-gen products. Hence, they are seen increasing investments in R&Ds. Moreover, companies are focusing on different strategies including acquisitions and strengthening their distribution networks in order to stay ahead of the competition.

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As per the Imperial College London, chronic diseases are expected to account for approximately 41 million deaths per year, which seven out of 10 demises worldwide. Of these deaths, approximately 17 million are considered to be premature. Hence, surge in cases of chronic diseases globally is resulting into increased need for cellular therapies in order to treat such disease conditions, which, in turn, is boosting the investments toward R&Ds, creating sales opportunities in the cell separation technologies market.

Cell Separation Technologies Market: Key Findings

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Cell Separation Technologies Market: Growth Boosters

Cell Separation Technologies Market: Regional Analysis

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Cell Separation Technologies Market: Key Players

Some of the key players profiled in the report are:

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Cell Separation Technologies Market Segmentation

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Cell Culture Market: Rise in outsourcing activities and expansion of biopharmaceutical manufacturers are expected to drive the cell culture market during the forecast period

Cell Culture Media, Sera, and Reagents Market: The global cell culture media, sera, and reagents market is majorly driven by growth and expansion of biotechnology & pharmaceutical companies and academic & research institutes.

Stem Cells Market: The global stem cells market is majorly driven by rising applications of stem cells in regenerative medicines. Increase in the number of chronic diseases such as cardiac diseases, diabetes, cancer, etc.

Cell Line Authentication and Characterization Tests Market: Increase in the geriatric population and surge in incidence of chronic diseases are projected to drive the global cell line authentication and characterization tests market.

CAR T-cell Therapy Market: The CAR T-cell therapy market is expected to clock a CAGR of 30.6% during the assessment period. The CAR T-cell therapy is known as a revolutionary treatment option for cancer, owing to its remarkably effective and durable clinical responses.

Cell & Tissue Preservation Market: Rise in investments in the field of regenerative medicine research is estimated to propel the market. Human blood, tissues, cells, and organs own the capability to heal damaged tissues and organs with long-term advantages.

Placental Stem Cell Therapy Market: Placental stem cell therapy market is driven by prominence in treatment of age-related disorders/diseases and increase in awareness about stem cell therapies are projected to drive the global market in the near future.

Biotherapeutics Cell Line Development Market: The market growth will be largely driven by research and development activities due to which, new solutions and technologies have gradually entered the market.

About Transparency Market Research

Transparency Market Research, a global market research company registered at Wilmington, Delaware, United States, provides custom research and consulting services. Our exclusive blend of quantitative forecasting and trends analysis provides forward-looking insights for thousands of decision makers. Our experienced team of Analysts, Researchers, and Consultants use proprietary data sources and various tools & techniques to gather and analyze information.

Our data repository is continuously updated and revised by a team of research experts, so that it always reflects the latest trends and information. With a broad research and analysis capability, Transparency Market Research employs rigorous primary and secondary research techniques in developing distinctive data sets and research material for business reports.

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Cell Separation Technologies Market Expands with Rise in Prevalence of Chronic Diseases, States TMR Study - GlobeNewswire

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WILMINGTON, Del., July 21, 2022 /PRNewswire/ --An in-depth demand analysis of dental membrane and bone graft substitutes found that massive demand for resorbable bone grafting materials presents value-grab opportunity. Companies in the dental membrane and bone graft substitutes market are actively leaning on development of novel biomaterials to meet the needs of bone grafting procedures. The TMR study projects the size of the market to surpass worth of US$ 1,337 Mn by 2031.

Advancements in periodontology are catalyzing introduction of new soft tissue regeneration, as emerging trends of the dental membrane and bone graft substitutes market underscore. Moreover, dental membrane and bone graft substitutes market projections in the TMR study have found that the use of xenograft for dental bone regeneration is anticipated to rise rapidly, and will unlock lucrative avenues. The fact that xenografts are cost-effective and show good results in bone tissue regeneration will spur the popularity of products in the segment.

Increasing number of bone regeneration procedures has led to the commercialization of novel biomaterials and dental bone grafts. The application of human cell sources in bone graft substitutes is growing, thus extending the canvas for companies in the dental membrane and bone graft substitutes market. Rise in oral disorders and injuries has impelled the need for bone substitute materials that can promise long-term survival rates in the patients.

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Key Findings of Dental Membrane and Bone Graft Substitutes Market Study

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Dental Membrane and Bone Graft Substitutes Market: Regional Growth Dynamics

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Dental Membrane and Bone Graft Substitutes Market: Key Players

High degree of fragmentation has characterized the competition landscape in the dental membrane and bone graft substitutes market, mainly due to presence of several prominent players. Some of the key players are Zimmer Biomet, OPKO Health, Inc., NovaBone Products, LLC., Nobel Biocare Services AG, Geistlich Pharma AG, Dentsply Sirona, Collagen Matrix, Inc., BioHorizons, and Institut Straumann AG.

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Dental Membrane and Bone Graft Substitutes Market Segmentation

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Non-Invasive Prenatal Testing Market: Non-invasive prenatal testing market was worth around US$ 1.3 Bn in 2018. The market is likely to develop at a CAGR of 16.4% during the forecast period, from 2019 to 2027.

Cell Culture Media, Sera, and Reagents Market: The global cell culture media, sera, and reagents market is majorly driven by growth and expansion of biotechnology & pharmaceutical companies and academic & research institutes.

Stem Cells Market: The global stem cells market is majorly driven by rising applications of stem cells in regenerative medicines. Increase in the number of chronic diseases such as cardiac diseases, diabetes, cancer, etc.

Cell Line Authentication and Characterization Tests Market: Increase in the geriatric population and surge in incidence of chronic diseases are projected to drive the global cell line authentication and characterization tests market.

CAR T-cell Therapy Market: The CAR T-cell therapy market is expected to clock a CAGR of 30.6% during the assessment period. The CAR T-cell therapy is known as a revolutionary treatment option for cancer, owing to its remarkably effective and durable clinical responses.

Cell & Tissue Preservation Market: Rise in investments in the field of regenerative medicine research is estimated to propel the market. Human blood, tissues, cells, and organs own the capability to heal damaged tissues and organs with long-term advantages.

mHealth Monitoring Diagnostic Medical Devices Market: The global mHealth monitoring diagnostic medical devices market was valued at US$ 29.05 Bn in 2018 and is projected to expand at a CAGR of 20.5% from 2019 to 2027.

Pediatric Medical Devices Market: The global pediatric medical devices market was valued at US$ 21,000 Mn in 2017 and is projected to expand at a CAGR of 8.0% from 2018 to 2026.

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